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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 215409

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NDA 215409 describes PENICILLAMINE, which is a drug marketed by Apotex, Breckenridge, Dr Reddys, Endo Operations, Granules, Invagen Pharms, Navinta Llc, Watson Labs Inc, Lupin Ltd, and Teva Pharms Usa, and is included in eleven NDAs. It is available from ten suppliers. Additional details are available on the PENICILLAMINE profile page.

The generic ingredient in PENICILLAMINE is penicillamine. There are eighteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the penicillamine profile page.

Summary for 215409

Tradename:	PENICILLAMINE
Applicant:	Breckenridge
Ingredient:	penicillamine
Patents:	0

Pharmacology for NDA: 215409

Medical Subject Heading (MeSH) Categories for 215409

Antidotes
Antirheumatic Agents
Chelating Agents

Suppliers and Packaging for NDA: 215409

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PENICILLAMINE	penicillamine	CAPSULE;ORAL	215409	ANDA	Breckenridge Pharmaceutical, Inc.	51991-974	51991-974-01	100 CAPSULE in 1 BOTTLE (51991-974-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	Aug 23, 2021	TE:	AB	RLD:	No

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